First Human Trial Tests Stem-cell-based Treatment For Heart Attacks

As a cell-based therapy, MSCs have a number of unique advantages: they can be taken from genetically distinct donors, are easy to prepare, and have a tendency to collect within injured areas. In animal models, MSCs not only home to regions of MI, but reduce infarct size and improve ejection fraction -- the portion of blood that is pumped out of the heart as a result of a heartbeat, and a primary indicator of the heart's health.

Researchers from ten medical centers across the United States, led by Joshua Hare, M.D., of the University of Miami, Miller School of Medicine, conducted a Phase 1 trial to assess the safety and efficacy of infusing MSCs intravenously to 53 patients within ten days of a heart attack. In the trial, patients were randomized to one of three doses: 0.5, 1.6 or 5 million MSCs/kg, and each dose was compared with placebo. The occurrence of treatment-related serious adverse events was evaluated over a six-month period, and efficacy was assessed using echocardiography.

Over the six month follow-up period, the stem cell-treated patients had lower rates of side effects such as cardiac arrhythmias, and had significant improvements in heart, lung and global function. Echocardiography showed improved heart function, particularly in those with large amounts of cardiac damage.

"This trial makes an important contribution in the field of stem cell-based treatments for heart disease by providing safety and efficacy data for a unique and promising type of stem cell to treat cardiac damage," said Joshua Hare, M.D., of the University of Miami and lead author of the study. "It's important to note that this study represents a first step, and, as in other disease categories, we must perform additional, larger trials to determine the real world application of mesenchymal stem cell therapy to fight heart disease."

Reference: Dr. Joshua Hare. "A Double-Blind, Randomized, Placebo Controlled Clinical Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Patients With Acute Myocardial Infarction" American College of Cardiology's Innovation in Intervention: i2 Summit in New Orleans, La.